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David S Boyer, VIBRANT study investigators; Efficacy and Safety of Intravitreal Aflibercept Injection (IAI) for Treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO): 24-Week Results of the VIBRANT Study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):604.
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The VIBRANT study was conducted to compare the efficacy and safety of IAI with laser photocoagulation for the treatment of macular edema secondary to BRVO.
VIBRANT was a multicenter, double-masked, active-controlled, randomized, phase 3 trial. Treatment-naïve patients with unilateral macular edema secondary to BRVO were included in the study if they were diagnosed within 12 months and had a BCVA between 73 and 24 letters (20/40 to 20/320 Snellen equivalent). In VIBRANT, patients received either IAI 2 mg every 4 weeks (n = 91) or laser (n = 92) from baseline to week 20. The primary efficacy endpoint was the proportion of patients who gained ≥15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. The secondary efficacy endpoints included the mean change from baseline in BCVA and central retinal thickness (CRT) at week 24.
The proportion of patients who gained ≥15 letters from baseline to week 24 was 53% in the IAI group compared with 27% in the laser group (P < .001). The mean improvement in BCVA from baseline to week 24 was 17.0 letters in the IAI group and 6.9 letters in the laser group (P < .0001). The mean reduction in CRT from baseline to week 24 was 280.5 μm in the IAI group and 128.8 μm in the laser group (P < .0001). The most common ocular adverse events in IAI patients were conjunctival hemorrhage (19.8%) and eye pain (4.4%). Over the 24 weeks of the study, traumatic cataract in an IAI patient was the only ocular serious adverse event (SAE) that occurred. The incidence of non-ocular SAEs was 8.8% in the IAI group and 9.8% in the laser group. One death due to pneumonia and one Anti-Platelet Trialists' Collaboration-defined event of non-fatal stroke occurred during the 24 weeks of the study, both in patients in the laser group. There were no cases of intraocular inflammation or endophthalmitis.
Monthly injections of intravitreal aflibercept were well tolerated and significantly improved visual acuity at week 24 in patients with macular edema secondary to BRVO.
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